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CRITICAL POINTS OF CONDUCTING DERMATOLOGY CLINICAL TRIALS

 

ACCURATE & RELIABLE CLINICAL TRIAL DATA ESTABLISHES & ENHANCES BRAND VALUE

Clinical trials are essentials for making Health Claims. Ranging from regular fever to complicated diseases like cancer, clinical research has established many treatments. On the same ground, clinical trials also have roots in the field of skin care and hair care.

Skin care and hair care market has grown many folds and the end consumer is quite aware these days. Not only doctors, regulatory authorities but consumers also look for efficacy & safety data of each product. Consumer wants to be sure before making the choice for any products. Correct & Accurate Clinical Trial data helps in building faith of the consumer about the product thus helps in establishing the Brand.

While planning for clinical studies for skin care & hair care products, the study design should be meticulously planned so that the data generated is accurate, analyzed correctly & presented in a beautiful manner. It must be publishable in International Journals of good reputation.

Some of the critical points which should be considered while designing the clinical study. These are:

  • Well-designed Clinical Trial Protocol: The protocol for the clinical study related to skin or hairs should be completely informative. All the investigations to be done, patients to be enrolled, type of medication to be given, etc, should be given in detail.
    • Categorization & differential diagnosis of disease condition is very crucial.
    • Study end points must be clearly defined
    • Patients with chronic skin disorders must be screened & enrolled very carefully keeping study inclusion & exclusion criteria in mind.
    • Proper lighting, appropriate patient positioning and prior facial skin preparation (gentle shaving for men, removal of make-up for women) are helpful in facilitating accurate assessment
  • Clinical photography: In the dermatological studies, as the studies are related to skin & hair problems, so symptoms are required to be clearly indicated. Due to this, the clinical photography is mandatory, either from smart phone or from camera. This will help in evaluating the results and difference in the condition of the patient before and after giving dosage during clinical trial. Photographs should be taken only after the patient’s consent and in accordance with the general medical guidelines.
  • Dermatologist: Always assign a well-experienced dermatologist as Principal investigator in the clinical trial. The dermatologist should be able to evaluate the visible signs over the skin or hairs of the patients.
  • Laboratory investigations: The diagnosis of the condition of patient with dermatological diseases should be accurately observed with all the biochemical, hematological, microbiological and histopathological tests.
  • Patient privacy: Privacy of the patient should be maintained while dressing, undressing, medical photography, examinations, etc.

References

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